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Evaluation of Emotional Disorders During Treatment by Interferon Beta in Relapsing-remitting Multiple Sclerosis Patients (SEPTIME)

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ClinicalTrials.gov Identifier: NCT01201343
Recruitment Status : Completed
First Posted : September 14, 2010
Results First Posted : April 11, 2012
Last Update Posted : December 27, 2013
Sponsor:
Collaborator:
Merck Serono S.A.S, France
Information provided by (Responsible Party):
Merck KGaA, Darmstadt, Germany

Tracking Information
First Submitted Date  ICMJE September 13, 2010
First Posted Date  ICMJE September 14, 2010
Results First Submitted Date  ICMJE March 15, 2012
Results First Posted Date  ICMJE April 11, 2012
Last Update Posted Date December 27, 2013
Study Start Date  ICMJE January 2005
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 15, 2012)
  • Change From Baseline in Emotional Dyscontrol Sub-score of the Depressive Mood Scale (Echelle d'Humeur Depressive [EHD]) Scale at Month 12 [ Time Frame: Baseline and Month 12 ]
    EHD scale is a tool to assess the depressive mood dimensions 'lack of emotional control' (emotional dyscontrol) and 'blunted effect' which comprises of 11 items graded in 4 degrees from 1 (not at all) to 4 (very much), where 4 corresponds to the worst state. The emotional dyscontrol sub-score is the sum of items 1, 2, 4, 5, 9, 10, and 11. The total possible score range from 1 (not at all) to 28 (very much), where 28 corresponds to worst state. (Radat F et al., 2007)
  • Change From Baseline in Emotional Dyscontrol Sub-score of the EHD Scale at Month 18 [ Time Frame: Baseline and Month 18 ]
    EHD scale is a tool to assess the depressive mood dimensions 'lack of emotional control' (emotional dyscontrol) and 'blunted effect' which comprises of 11 items graded in 4 degrees from 1 (not at all) to 4 (very much), where 4 corresponds to the worst state. The emotional dyscontrol sub-score is the sum of items 1, 2, 4, 5, 9, 10, and 11. The total possible score range from 1 (not at all) to 28 (very much), where 28 corresponds to worst state. (Radat F et al., 2007)
  • Change From Baseline in Emotional Dyscontrol Sub-score of the EHD Scale at Month 24 [ Time Frame: Baseline and Month 24 ]
    EHD scale is a tool to assess the depressive mood dimensions 'lack of emotional control' (emotional dyscontrol) and 'blunted effect' which comprises of 11 items graded in 4 degrees from 1 (not at all) to 4 (very much), where 4 corresponds to the worst state. The emotional dyscontrol sub-score is the sum of items 1, 2, 4, 5, 9, 10, and 11. The total possible score range from 1 (not at all) to 28 (very much), where 28 corresponds to worst state. (Radat F et al., 2007)
Original Primary Outcome Measures  ICMJE
 (submitted: September 13, 2010)
Evolution of (emotional dyscontrol) the depressive mood scale (EHD) score before and after treatment [ Time Frame: Day -15, Day-7, Day 0, Month 1, 2, 3, 4, 5, 6, 9, 12, 24 ]
Comparison of area under curve (AUC), maximal values before and after treatment.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 15, 2012)
  • Change From Baseline in Emotional Abrasion Sub-score of the EHD Scale at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 [ Time Frame: Baseline, Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 ]
    EHD scale is a tool to assess the depressive mood dimensions 'lack of emotional control' (emotional dyscontrol) and 'blunted effect' which comprises of 11 items graded in 4 degrees from 1 (not at all) to 4 (very much), where 4 corresponds to the worst state. The emotional abrasion sub-score is the sum of items 3, 6, 7, and 8. The total possible score range from 1 (not at all) to 16 (very much), where 16 corresponds to worst state. (Radat F et al., 2007)
  • Change From Baseline in State-trait Anxiety Inventory (STAI State) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 [ Time Frame: Baseline, Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 ]
    STAI state scale is an auto-evaluation scale for anxiety. This scale includes 20 items that allow quantifying feeling of apprehension, tension, nervousness and worry that the participant feels at the time of the completion of the questionnaire. The 20 items are graded from 1 (no) to 4 (yes), where 'yes' corresponds to the best state for items 1, 2, 5, 8, 10, 11, 15, 16, 19, 20 (scoring was reversed before calculation of total score); and to the worst state for items 3, 4, 6, 7, 9, 12, 13, 14, 17, 18. The total score ranged from 1 (best state) to 80 (worst state). (Spielberger CD et al., 1983)
  • Change From Baseline in Center for Epidemiologic Studies Depression (CES-D) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 [ Time Frame: Baseline, Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 ]
    CES-D is an auto-questionnaire including 20 items to screen for depressive feelings and behaviour. The 20 items of this scale are graded from 0 (never) to 3 (always), where 3 corresponds to the most severe state with the exception of items 4, 8, 12 and 16 (scoring was reversed before the calculation of the total score). Total score ranged from 0 (never) to 60 (always), where 60 corresponds to most severe state. (Radloff LS, 1977)
  • Change From Baseline in Center for State-trait Anger Expression Inventory 2 (STAXI-state) Score at Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 [ Time Frame: Baseline, Months 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 ]
    STAXI-state scale measures the intensity of anger as an emotional state (state anger) and the disposition to experience angry feelings as a personality trait (trait anger). In this study only 1 of the original 6 scales was used, the state anger scale, which measures the intensity of anger at a given moment as emotional state. This scale consists of 15 items graded in 4 degrees from 1 (not at all) to 4 (very much), where 4 corresponds to the worst state. The total score range from 1 (not at all) to 60 (very much), where 60 corresponds to the worst state. (Spielberger CD, 1996)
  • Change From Baseline in Fatigue Score at Months 1, 2, 3, 6, 12 and 24 [ Time Frame: Baseline, Months 1, 2, 3, 6, 12, and 24 ]
    Fatigue scale was derived from the United Kingdom Neurological Disability Scale (UKNDS), and evaluates fatigue according to the participant's subjective impression and the functional disability that it causes. 'Yes' or 'No' answers result in a score that ranges from 0 to 5, where a score 5 shows worse state. (Sharrack B et al., 1999)
Original Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2010)
  • Evolution of the mean score (emotional abrasion) of EHD along the study duration [ Time Frame: Day -15, Day-7, Day 0, Month 1, 2, 3, 4, 5, 6, 9, 12, 24 ]
  • Evolution of the mean score (emotional abrasion) of STAI-Etat (state trait anger scale) along the study duration [ Time Frame: Day -15, Day-7, Day 0, Month 1, 2, 3, 4, 5, 6, 9, 12, 24 ]
  • Evolution of the mean score (emotional abrasion) of Center for Epidemiological Studies Depression Scale (CES-D) along the study duration [ Time Frame: Day -15, Day-7, Day 0, Month 1, 2, 3, 4, 5, 6, 9, 12, 24 ]
  • Evolution of the mean score (emotional abrasion) of Anger expression inventory (STAXI ETAT) along the study duration [ Time Frame: Day -15, Day-7, Day 0, Month 1, 2, 3, 4, 5, 6, 9, 12, 24 ]
  • : Evolution of the mean score (emotional abrasion) of fatigue scores along the study duration [ Time Frame: Day -15, Day-7, Day 0, Month 1, 2, 3, 4, 5, 6, 9, 12, 24 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Emotional Disorders During Treatment by Interferon Beta in Relapsing-remitting Multiple Sclerosis Patients
Official Title  ICMJE Evaluation of Emotional Disorders During Treatment by Interferon Beta in Relapsing-remitting Multiple Sclerosis Patients
Brief Summary This study is planned to evaluate emotional disorders during treatment by interferon (IFN) beta in relapsing remitting multiple sclerosis (RRMS) subjects. This is an open-label exploratory study with no change of therapeutic behavior but with standardized neuropsychologic follow-up.
Detailed Description This study is planned to evaluate emotional disorders during treatment by IFN beta in RRMS subjects. This is an open-label, prospective, interventional, multicentric study with no change of therapeutic behavior but with standardized neuropsychologic follow-up. Subjects will undergo 13 evaluations (categorical and dimensional evaluations), 3 evaluations will be performed before the treatment (Baseline, Day 7 and 15) and 10 evaluations after the treatment (Month 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Multiple Sclerosis, Relapsing, Remitting
Intervention  ICMJE Drug: Interferon beta-1a
Other Name: Rebif
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 13, 2010)
79
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2010
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male and female subjects aged ≥ 18 years
  • Subjects with RRMS
  • Subjects with at least 2 relapses in the past two years (with last relapse finished or finishing)
  • Subjects with indication of IFN beta treatment determined by the investigator
  • Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

  • Subjects with secondary progressive multiple sclerosis (MS) without relapse
  • Subjects with ongoing acute relapse
  • Subjects already being treated with interferon
  • Subjects with corticoid therapy for less than 15 days
  • Subjects presenting acute major depression or treated with anti-depressant therapy
  • Subjects involved in another therapeutic study
  • Subjects with any condition which could interfere with a good compliance of this study
  • Other protocol-defined exclusion criteria may apply
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01201343
Other Study ID Numbers  ICMJE IMP 25206
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Merck KGaA, Darmstadt, Germany
Study Sponsor  ICMJE Merck KGaA, Darmstadt, Germany
Collaborators  ICMJE Merck Serono S.A.S, France
Investigators  ICMJE
Principal Investigator: Bruno Brochet, MD, Prof. Hôpital PELLEGRIN, Place Amélie Raba Léon 33076 BORDEAUX Cedex
PRS Account Merck KGaA, Darmstadt, Germany
Verification Date December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP